Unique ID issued by UMIN | UMIN000024379 |
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Receipt number | R000027978 |
Scientific Title | The effect of ramelteon to prevent emergence agitation after general anesthesia in pediatric patients : a randomized placebo- controlled trial |
Date of disclosure of the study information | 2016/10/24 |
Last modified on | 2019/05/15 12:28:49 |
The effect of ramelteon to prevent emergence agitation after general anesthesia in pediatric patients : a randomized placebo- controlled trial
The effect of ramelteon to prevent emergence agitation after general anesthesia in pediatric patients : a randomized placebo- controlled trial
The effect of ramelteon to prevent emergence agitation after general anesthesia in pediatric patients : a randomized placebo- controlled trial
The effect of ramelteon to prevent emergence agitation after general anesthesia in pediatric patients : a randomized placebo- controlled trial
Japan |
The pediatric patients undergoing tonsillectomy
Anesthesiology |
Others
NO
To investigate the effect of ramelteon to prevent emergence agitation after general anesthesia in pediatric patients
Safety,Efficacy
The emergence agitation in PACU(PAED scale>10)
Interventional
Parallel
Randomized
Cluster
Double blind -all involved are blinded
Placebo
2
Prevention
Medicine |
45-60min before anesthesia, pateients take ramelteon0.1mg/kg melted with syrup.
45-60min before anesthesia, pateients take lactose melted with syrup.
18 | months-old | <= |
120 | months-old | > |
Male and Female
American Society of Anesthesiologists physical status 1 or 2 and scheduled to undergo tonsillectomy under general anesthesia are included in this study.
Patients are excluded from the study if they have the medial history such as mental retardation, mental disease, taking psycotropics or anticonvulsants, cardiac disease and cerebral surgery. Patients who enter hospital on the a.m. of the day of surgery are also excluded.
50
1st name | Maya |
Middle name | |
Last name | Komazaki |
Kanagawa childrens medical centre
Department of Anesthesiology
232-8555
2-138-4 Mutsukawa, Minami-ku, Yokohama, Kanagawa, Japan
045-711-2351
maya.koma05peony.root.dike@gmail.com
1st name | Maya |
Middle name | |
Last name | Komazaki |
Kanagawa Children's Medical Centre
Department of Anesthesiology
232-8555
2-138-4 Mutsukawa, Minami-ku, Yokohama, Kanagawa, Japan
045-711-2351
maya.koma05peony.root.dike@gmail.com
Kanagawa children's medical centre
Ministry of Education, Culture, Sports, Science and Technology
Japanese Governmental office
IRB of Knagawa Children's Medical center
2-138-4 Mutsukawa, Minami-ku, Yokohama, Kanagawa, Japan
045-711-2351
nakajima.13011@kanagawa-pho.jp
NO
2016 | Year | 10 | Month | 24 | Day |
Unpublished
48
Completed
2016 | Year | 10 | Month | 01 | Day |
2016 | Year | 09 | Month | 20 | Day |
2016 | Year | 10 | Month | 24 | Day |
2018 | Year | 09 | Month | 30 | Day |
2018 | Year | 10 | Month | 01 | Day |
2018 | Year | 10 | Month | 01 | Day |
2018 | Year | 10 | Month | 06 | Day |
2016 | Year | 10 | Month | 12 | Day |
2019 | Year | 05 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027978
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